Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
Fragmin 7,500 IU/0.3 ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. |
Fragmin 7,500 IU: single dose syringe containing dalteparin sodium 7,500 IU (anti-Factor Xa*) in 0.3 ml solution for injection equivalent to 25,000 IU/ml.
For excipients, see 6.1
Fragmin does not contain preservatives.
* Potency is described in International anti-Factor Xa units (IU) of the 1st International Standard for Low Molecular Weight Heparin.
| Active Ingredient | Description | |
|---|---|---|
| Dalteparin |
Dalteparin is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of Factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate Factor Xa inhibition than to prolong plasma clotting time (APTT). |
| List of Excipients |
|---|
|
Water for Injections (Ph. Eur.) Sodium hydroxide or hydrochloric acid for pH adjustment. |
Fragmin 7,500 IU/0.3ml solution for injection is supplied in a single dose pre-filled syringe (Type I glass) with a needle shield (rubber), plunger stopper (chlorobutyl rubber), a plunger rod (polypropylene) and a needle-trap as a safety feature. The needle shield may contain latex (see section 4.4).
Each pack contains 10 syringes.
Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
PL 00057/0985
26 June 2002 / 23 April 2006
| Drug | Countries | |
|---|---|---|
| FRAGMIN | Austria, Brazil, Canada, Germany, Estonia, Spain, Finland, Croatia, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
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